- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01299246
The Effectiveness of Improving Self-care After Counseling for the Diabetics Mellitus Foots Around Chiayi Region
February 17, 2011 updated by: Chang Gung Memorial Hospital
The Effectiveness of Improving Self-care and Health Status After Promoting Counseling for the Diabetics Mellitus Patients With DM Foots Around Yunlin and Chiayi Region
Objectives:
Preventing diabetic foot problems (DFP) and associated consequences, such as amputation, is a critical in rural regions. The objective is to present on the association of non-invasive DFP assessment tools and physiological indicators for the early detection of DFP among rural cases of diabetes in Taiwan.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
- Peripheral neurological assessment was carried out using Michigan Neuropathy Screening Instrument (MNSI). The diabetes nurse educators assessed five parameters on both feet and counted the total points, ranging from 0 to10: (1) Appearance of feet (normal/abnormal with 0 and 1 point); if abnormal, then inspection of lower limbs for deformities, dry skin, fissure, calluses or infection was carried out; (2) Identification of foot ulceration (yes/no with 0 and 1 point); (3) Vibration perception of the big toe (present/decreased/absent, with 0, 0,5 and 1 points); (4) Ankle reflexes (present/reinforcement/absent, with 0, 0,5 and 1 points); (5) touch-pressure sensation test with a 10 g Semmes-Weinstein monofilament (normal/reduced/absent, with 0, 0,5 and 1 points). When an MNSI summative score was ≥2 points with neuropathy, patients were referred to the teaching hospitals for further evaluation. The MNSI procedures took 6-8 minutes for each participant.
- Peripheral vascular assessment: three parameters were used to assess peripheral vascular function by trained nurses. (a) The Cardio-Vision Model MS-2000 was used to detect Ankle Brachial Index (ABI), assessed by research nurses. Values of ABI were classified as ≥0.9 normal and <0.9 abnormal. (b) Palpable pedal, posterior tibias and popliteal pulses were recorded as absent, weak or present. (c) Capillary refill time was done by pressing the tip of the toenail for two seconds, and taking the time for the blanched area to turn pink again. If the return time took >2 seconds, this was taken as ischemia. Assessing of all 3 parameters of peripheral vascular assessment took 10-15 minutes for each participant.
- Diabetic foot risk assessment was assessed by plastic surgeons: (a) King's College classification (KC) contained six stages of condition: not at risk, at risk, ulcer, cellulites, necrosis and amputation. (b) the Texas risk classification (TRC) system was divided into six categories in origin. We re-categorized three levels: low risk, at risk, and high risk.
- The blood glucose, total cholesterol, and low density of lipoprotein cholesterol were drawn from the last 1-2 month diabetes passport record for each subject. Blood pressure was measured according to standard procedures by the nurses during the study. Body mass index was calculated for each participant using the standard formula (weight in kilograms divided by square of the height in meters). Waist circumference in centimeter was used to measure central obesity, measuring the mid-abdominal distance between the last rib margin and the iliac crest.
Study Type
Interventional
Enrollment (Actual)
386
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Chiayi, Taiwan, 61363
- Graduate Institute of Nursing, Chang Gung Institute of Technology, Chiayi Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diabetics mellitus patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: improving self-care
|
Peripheral neurological assessment was carried out using MNSI.
The diabetes nurse educators assessed five parameters on both feet and counted the total points, ranging from 0 to10: (1) Appearance of feet; if abnormal, then inspection of lower limbs for deformities was carried out; (2) Identification of foot ulceration; (3) Vibration perception of the big toe; (4) Ankle reflexes; (5) touch-pressure sensation test with a 10 g Semmes-Weinstein monofilament.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of the residents in detecting the early neurovasculopathy
Time Frame: 1 year
|
It is shown that using the MNSI and ABI as community screening tools can be useful in detecting the early neurovasculopathy for diabetic rural residents.
In addition, where an ABI machine is unavailable, performing MNSI using primary healthcare providers might be cost-effective.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mei-Yen Chen, Ph.D., Graduate Institute of Nursing, Chang Gung Institute of Technology, Chiayi Campus, Taiwan. Tel: 886 (5) 3628800 ext. 2201, Fax: 886-5-3628866, Email: meiyen@gw.cgit.edu.tw
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Anticipated)
November 1, 2012
Study Completion (Anticipated)
July 1, 2013
Study Registration Dates
First Submitted
January 30, 2011
First Submitted That Met QC Criteria
February 17, 2011
First Posted (Estimate)
February 18, 2011
Study Record Updates
Last Update Posted (Estimate)
February 18, 2011
Last Update Submitted That Met QC Criteria
February 17, 2011
Last Verified
October 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Skin Diseases
- Kidney Diseases
- Urologic Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Foot Ulcer
- Diabetes Mellitus, Type 2
- Diabetic Foot
- Diabetic Nephropathies
Other Study ID Numbers
- 98-2224-B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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